Wysa Digital Chatbot for Eating Disorders

(EMBody Trial)

Overseen By Marianna Horton, B.S./B.A.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Age, Smartphone, English, Residency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital chatbot program designed to help prevent eating disorders in teens. It uses cognitive-behavioral therapy (CBT) modules to provide education and exercises on healthy eating habits and body image. The trial compares two groups: one uses the Wysa Digital Chatbot Program immediately, while the other waits six months. Teens who might be a good fit have a smartphone, live in the U.S., speak English, and are at risk for an eating disorder but not currently in treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Wysa Digital Chatbot Program is safe for adolescents?

Research has shown that the Wysa Digital Chatbot, used for mental health support, has shown promise in past studies. One study examined its use with healthcare workers and found it to be a practical option for mental health support, indicating that the chatbot is generally safe and well-received.

Another source notes that Wysa follows best practices in safety and privacy. Its widespread use suggests a strong safety record.

The chatbot has been used in various mental health settings. Although specific details on side effects aren't provided, its extensive use and integration with care models suggest a low risk of negative outcomes. Therefore, it appears to be a safe choice for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wysa Digital Chatbot Program for eating disorders because it offers a unique, tech-driven approach. Unlike traditional treatments like in-person therapy or medication, this digital chatbot delivers Cognitive Behavioral Therapy (CBT) through an accessible, user-friendly app. It features five modules focusing on psychoeducation and exercises for regular eating and body image improvement. This innovative method allows for flexible, on-demand support, making it a potentially game-changing tool for those seeking help without the barriers of traditional therapy settings.

What evidence suggests that the Wysa Digital Chatbot Program is effective for eating disorders?

Research has shown that therapy chatbots, such as the Wysa Digital Chatbot, could help treat mental health issues. Studies have found that these chatbots can reduce symptoms of depression and anxiety, suggesting they might also assist with eating disorders. In this trial, participants in the Chatbot Intervention Condition will access the Wysa Digital Chatbot Program, which includes five CBT-based modules for three months. The Wysa app, known for supporting mental health, was tested with healthcare workers and demonstrated its ability to help manage stress and mental health. These findings suggest that the Wysa Digital Chatbot could be a useful tool for preventing eating disorders in teenagers. ^{1 2 4 6 7}

Who Is on the Research Team?

Ellen Fitzsimmons-Craft, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for US teens aged 13-17 who speak English, own a smartphone, and are at risk for an eating disorder but not currently in treatment. It's not open to those outside this age range, non-US residents, without a smartphone, or already receiving eating disorder care.

Inclusion Criteria

Speaks English

US resident

I am between 13 and 17 years old.

Exclusion Criteria

Does not own a smartphone

Does not speak English

Lives outside the US

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chatbot Intervention

Participants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image.

3 months

Waitlist Control

Participants in the waitlist control group receive access to the digital chatbot program after 6 months and completion of the study.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Wysa Digital Chatbot Program

Trial Overview The study is evaluating the effectiveness of Wysa Digital Chatbot Program as a preventive tool against eating disorders among adolescents. Participants will interact with the chatbot designed to help manage thoughts and behaviors related to body image and eating.

How Is the Trial Designed?

Group I: Chatbot Intervention Condition Experimental Treatment 1 Intervention

Participants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image.

Group II: Waitlist Control Active Control 1 Intervention

Participants receive access to the digital chatbot program after 6 months and completion of the study.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07218302

NCT07218302 | Eating Disorder Chatbot Optimization The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11482850/

Eating Disorders Care and the Promises and Pitfalls of ... These results demonstrate the effectiveness of a fully generative AI therapy chatbot for treating mental health disorders, showing promise for CHR-FED, MDD ...

3. apsa.org apsa.org/are-therapy-chatbots-effective-for-depression-and-anxiety/

Are Therapy Chatbots Effective for Depression and Anxiety ... The therapeutic effectiveness of artificial intelligence-based chatbots in alleviation of depressive and anxiety symptoms in short-course treatments.

4. formative.jmir.org formative.jmir.org/2024/1/e51858

AI-Led Mental Health Support (Wysa) for Health Care Workers ... This study explores the feasibility of using Wysa, an artificial intelligence–led mental health app, among health care workers.

5. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2023.1251016/full

Qualitative analysis of mental health conversational agents ... This study aimed to identify common themes of messages sent to a mental health CA (Wysa) related to ASD by general users and users that identify as having ASD.

6. wysa.com wysa.com/

Wysa - Everyday Mental Health People everywhere are turning to AI. Wysa is the safe, evidence-based alternative. It is always available and designed to integrate with your care model.

7. source.washu.edu source.washu.edu/2025/04/eating-disorder-chat-tool-could-improve-access-to-care/

Eating disorder chat tool could improve access to care The tool will be hosted by Wysa, a global AI-led mental health company recognized for its best practices across clinical safety and privacy. The ...